1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [deeparaj1993@gmail.com].
   


6. For how long will this data be available start date provided 29-02-2024 and end date provided 28-02-2029?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

The conventional neurological trauma assessment encompasses two primary components: the Glasgow Coma Scale (GCS) score and the pupillary evaluation. When compared to the application of Quantitative Pupillometry (QP), a 22% discrepancy rate among nurses has been demonstrated when detecting anisocoria. Pupillometry has been recently evaluated for prediction of neurological outcomes after TBI in the western population. These early studies have found pupillometry to be useful for outcome prediction. 

The automated pupillometer (Neurolight®, IDMed Company, Marseilles, France) provides objective information about the baseline pupil diameter (PD) in mm, the variation in PD with light reflex (in %), the constriction velocity (CV), latency and Quantitative Pupillary Index or the amplitude of photomotor reflex (QPi), ranging from 0-5 (a composite score based on the reactivity of the pupil to light). With administration of painful stimulus, pupillary dilatation occurs and therefore, PD increases. Since, the PD increases, the change in PD with light stimulation, also increases with noxious stimuli. This would lead to increase in the variation, CV and also an increase in QPi. The role of pupillary reactivity to painful stimuli as a prognostic determinant has not been explored in patients with TBI. So in this study, we intend to evaluate prognostic ability of QP (based on pupillary reactivity to light stimulation) during noxious stimulus, in the pupil contralateral to the injured side in moderate to severe TBI patients in terms of Glasgow Outcome Scale Extended (GOSE).

Optic nerve sheath diameter (ONSD) is a tool for non-invasive estimation of ICP and may allow detection of increase in ICP. An increase in ONSD has also been shown to be associated with unfavourable outcome in patients with TBI. We also intend to study correlation of ONSD with QPi. Pain assessment by pupillometer is based on the principle that pupil dilates with application of noxious stimulation and pupillary light reflex amplitude (PLRA), which is the difference between PD before and after light exposure, increases after application of a noxious stimulus under general anaesthesia. This has been proven to be useful to assess pain in conscious adult patients. Although there is literature where pupillometer has been used to guide intraoperative analgesic administration, there is not much evidence on the effect of opioids on pupillary parameters which will also be explored in the study. As secondary outcomes, we also intend to explore correlation of pain assessment using BPS scoring, consciousness (BIS) and ICP with pupillometric parameters.